Allogeneic Hematopoietic Stem Cell TransplantationPhase 2ADAPTNCT06028828
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Fludarabine, Melphalan and Total Body Irradiation in people with Allogeneic Hematopoietic Stem Cell Transplantation and Allogeneic Stem Cell Transplantation, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Hematologic Malignancies
- What is being tested?
- Fludarabine, Melphalan and Total Body Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-70 years
- Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
- Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
- Karnofsky performance >70%
- Adequate major organ system function as demonstrated by:
- Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
Show all 10Show fewer
- Bilirubin equal or less than 1.5 mg/dl except for Gilbert's disease. ALT or AST equal or less than 200 IU/ml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.
- Left ventricular ejection fraction equal or greater than 40%.
- Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
- Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
Who cannot join
- Inability to comply with medical recommendations or follow-up
- Pregnancy
- Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
- Has active CNS or ocular disease involvement within 3 months
- Patients with primary CNS lymphoma
- Patients who require modifications of the conditional regimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, 92868
Stefan O Ciurea, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)
This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
Read the detailed description
Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis.
Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy.
All patients will be monitored for safety and efficacy up to 2 years post-transplantation.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Hematologic Malignancies
- Being tested
- Fludarabine, Melphalan, Total Body Irradiation
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell transplantation, AHSCT, Hematologic malignancies, Melphalan, Hematopoietic stem cell transplant -composite risk
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Given Day-5, Day-4, Day-3, Day-2
MelphalanDrug
Given Day-5
Total Body IrradiationRadiation
Also called TBI
Given Day-1
| Study group | Role | What they receive |
|---|---|---|
| Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT | Experimental | Patients will be treated with allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on their Hematopoietic Cell Transplant - Composite Risk (HCT-CR), age, and Karnofski performance status (KPS). Receives: Drug: Fludarabine; Drug: Melphalan; Radiation: Total Body Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as the time from stem cell infusion to time of disease relapse or death from any cause; data for patients who were alive without relapse will be censored at the date of last contact.
Measured: Up to 48 months
Secondary outcomes (6)
Overall survival (OS)
OS is defined as the time from stem cell infusion until death from any cause. Data of patients who were alive without relapse will be censored at the date of last contact.
Measured: Up to 48 months
Cumulative incidence of Graft-Versus-Host-Free, relapse-free survival (GRFS)
GRFS is defined as time from stem cell infusion to time of the first event among acute GVHD grades 3-4, extensive chronic GVHD, relapse, and death. Data of patients who are event-free will be censored at the date of last contact.
Measured: Up to 48 months
Cumulative incidence of relapse
Relapse is defined as re-occurrence of the disease after stem cell infusion. Cumulative incidence of relapse will be measured from date of stem cell infusion to date of disease relapse. Death without disease relapse is considered a competing risk for relapse. Data of patients who are alive without disease relapse will be censored at the date of last contact.
Measured: Up to 48 months
Cumulative incidence of Non-Relapse Mortality (NRM)
NRM is defined as death related to AHSCT during continuous complete remission. Cumulative incidence of NRM will be measured from date of stem cell infusion to date of death. Disease relapse is considered a competing risk for NRM. Data of patients who are alive without disease relapse will be censored at the date of last contact.
Measured: Up to 48 months
Cumulative incidence of acute and chronic graft versus host disease (GVHD)
Acute and chronic GVHD will be measured from date of stem cell infusion to date of the event. Death without GVHD is considered a competing risk for GVHD. Patients who are alive without GVHD will be censored at the date of last contact.
Measured: Up to 48 months
Area Under the Curve (AUC) of Melphalan
AUC will be used to determine the pharmacokinetic of melphalan after the infusion on D-5. Data will be summarized using descriptive statistics.
Measured: From melphalan infusion start time to 22 hours after the infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start11 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Octavian Ciurea, University of California, Irvine
- Investigators
- Stefan O. Ciurea, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028828
- Sponsor's protocol ID
- 3095
- Other IDs
- UCI 21-90
- Acronym
- ADAPT
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation (ADAPT)
- ClinicalTrials.gov ID
- NCT06028828
- Acronym / sponsor ID
- ADAPT / 3095
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell Transplantation, Hematologic Malignancies
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic Stem Cell transplantation, AHSCT, Hematologic malignancies, Melphalan, Hematopoietic stem cell transplant -composite risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
Detailed description
Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis.
Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy.
All patients will be monitored for safety and efficacy up to 2 years post-transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT | Experimental | Drug: Fludarabine, Drug: Melphalan, Radiation: Total Body IrradiationPatients will be treated with allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on their Hematopoietic Cell Transplant - Composite Risk (HCT-CR), age, and Karnofski performance status (KPS). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged 18-70 years
- Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
- Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
- Karnofsky performance >70%
- Adequate major organ system function as demonstrated by:
Key exclusion criteria (6 listed)
- Inability to comply with medical recommendations or follow-up
- Pregnancy
- Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
- Has active CNS or ocular disease involvement within 3 months
- Patients with primary CNS lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineGiven Day-5, Day-4, Day-3, Day-2 | Drug | Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT |
| MelphalanGiven Day-5 | Drug | Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT |
| Total Body IrradiationAlso: TBIGiven Day-1 | Radiation | Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 48 months
PFS is defined as the time from stem cell infusion to time of disease relapse or death from any cause; data for patients who were alive without relapse will be censored at the date of last contact.
6 secondary outcomes
Overall survival (OS)
Time frame: Up to 48 months
Cumulative incidence of Graft-Versus-Host-Free, relapse-free survival (GRFS)
Time frame: Up to 48 months
Cumulative incidence of relapse
Time frame: Up to 48 months
Cumulative incidence of Non-Relapse Mortality (NRM)
Time frame: Up to 48 months
Cumulative incidence of acute and chronic graft versus host disease (GVHD)
Time frame: Up to 48 months
Area Under the Curve (AUC) of Melphalan
Time frame: From melphalan infusion start time to 22 hours after the infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Related trials for Allogeneic Hematopoietic Stem Cell Transplantation
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Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
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RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Stefan O. Ciurea, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Melphalan and Total Body Irradiation in people with Allogeneic Hematopoietic Stem Cell Transplantation and Allogeneic Stem Cell Transplantation, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.